Life Science Filter
Protecting Life with Biosecurity Filtration
Sterilizing Filters LOPAC INNOVEX SP
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LOPAC INNOVEX SP series filters are made of modified polyethersulfone membrane (PES) with good hydrophilicity and low protein adsorption. They are suitable for sterilizing filtration of process fluid, buffer and column protection.
Advanced Bio-Pharma Filtration Solutions
Enhance yield and ensure compliance with Feature-Tec’s precision-engineered filtration technologies.
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Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.
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Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.
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Expert Services: Full Process Validation & Technical Support.
International Standards & Regulatory Compliance
Feature-Tec Sterilizing-Grade Filter Certifications & Compliance
1、Core Function & Definition (Sterilizing-Grade Identity)
Standard
Description
ASTM F838
Validated to the internationally recognized "gold standard" for bacterial retention in sterilizing-grade filters
PDA TR No. 26
Establishes scientific correlation between integrity testing and bacterial retention performance
21 CFR 211.65
Compliant with FDA requirements for material safety of pharmaceutical manufacturing equipment
2、Biosafety & Patient Safety
Standard
Description
USP <88> / ISO 10993
Validated for biocompatibility per USP Class VI and ISO 10993 requirements
USP <85> / EP 2.6.14
Complies with bacterial endotoxin limits to support injectable product safety
ICH Q3D / USP <232>
Complies with elemental impurity control requirements
USP <788>
Complies with sub-visible particulate matter requirements for injectable quality
BPOG Protocol (2014)
Characterized per BPOG extractables protocol to support chemical compatibility assessment
3、Manufacturing Process & Batch Consistency
Standard
Description
ISO 11137 (VDmax)
Validated for gamma irradiation sterilization, achieving SAL 10⁻⁶ sterility assurance level
ICH Q1A (R2), Q1E
Validated through accelerated and long-term stability studies to support claimed shelf life
ISO 9001 / 13485
Certified to quality management systems, ensuring consistent product quality and full traceability
4、Process Operations & Performance
Standard
Description
USP <643> / <645>
Post-flush residuals comply with USP Water for Injection (WFI) quality requirements
ISTA 2A / ASTM F2096
Validated for packaging integrity to maintain sterile barrier during transportation
5、Regulatory & Supply Chain Compliance Statements
Standard
Description
21 CFR 177-182
Materials comply with FDA requirements for indirect food-contact materials
GMO (EC) / BSE/TSE / BPA
Supporting declarations available: Non-GMO, BSE/TSE-Free, BPA-Free (where applicable)
Product Feature
• Reliable bacterial retention
• Excellent chemical compatibility (pH 1-14)
• Unique double layer membrane design for increased loading capacity
• Rugged construction for multiple sterilization cycles
Applications
• Sterilization filtration of cell culture media
• Buffer filtration
• Pre-Column / Pre-Ultrafiltration Protective Filtration
• Sterilization Filtration of end productsDimensions
Parameter Disc Filters Capsule Filters Cartridge Filters Nominal Size (inches) / S / 2.5" / 5" / 10" 2.5" / 5" / 10" / 20" / 30" (φ63 / φ70) Filtration Area (Single Layer) 3.5cm² / 20cm² S: 180cm²2.5": 0.073m²5": 0.23m²10": 0.63m² φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m² Filtration Area (Double Layer) 3.5cm² / 20cm² S: 160cm²2.5": 0.065m²5": 0.20m²10": 0.60m² φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m² Pore Size 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm Materials of Construction Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES Max Forward Differential Pressure 5bar (72.5psi) @20°C L/M: 5bar (72.5psi) @20°C / 3bar (43.5psi) @50°CS: 4bar (58psi) @20°C 5bar (72.5psi) @20°C / 2bar (29psi) @80°C Max Reverse Differential Pressure 2bar (29psi) @20°C 2bar (29psi) @20°C / 1.5bar (22psi) @50°C 2bar (29psi) @20°C Sterilization Resistant to autoclaving and irradiation Autoclave: 134°C30min25 timesElectron beam irradiation: <50 kGy Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar) Bacterial Interception >10⁷cfu / cm² B.diminuta (ATCC 19146) >10⁷cfu / cm² B.diminuta (ATCC 19146) >10⁷cfu / cm² B.diminuta (ATCC 19146) Component Material Toxicity Meets USP<88> Class VI Biological Reactivity criteria Meets USP<88> Class VI Biological Reactivity criteria Meets USP<88> Class VI Biological Reactivity criteria Cleanness Complies with FDA 21 CFR 211.72, 210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72, 210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72, 210.3(b)(5)(6) & USP<788> Ingredient Material Toxicity Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards Bacterial Endotoxin Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) Integrity 100% integrity tested before factory delivery 100% integrity tested before factory delivery 100% integrity tested before factory delivery Production Environment 100,000 class clean room 100,000 class clean room 100,000 class clean room -
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Contact
Hotline: (+86)400-820-6150
Email: marketing@feature-tec.com
Address: 8/F, Block A, Building 3, Tianhua Information Technology Park, 299 Longcao Road, Xuhui District, Shanghai